MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO STRYKER ADAPT(R) PLATFORM; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Catalog Number 7700-600-000

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during an ent procedure the navigation system shut down multiple times leading to a total of a 2.5 hour delays and the administration of additional anesthesia.The procedure was completed successfully without any adverse consequences.

Manufacturer Narrative

Additional information: the reported event that the system has shut down multiple times on (b)(6) 2016 was confirmed based on an evaluation of the systems log files.The review of the log files did not show any error and the system was not returned for evaluation; therefore, a definitive root cause could not be identified.A damaged electrical component of the computer or a loose, damaged cable connection may have caused or contributed to the reported event.

Event Description

It was reported that during an ent procedure the navigation system shut down multiple times leading to a total of a 2.5 hour delays and the administration of additional anesthesia.The procedure was completed successfully without any adverse consequences.

• Brand Name: STRYKER ADAPT(R) PLATFORM
• Type of Device: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6113800
• MDR Text Key: 60366385
• Report Number: 0001811755-2016-02759
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141551
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7700-600-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1